Image Quality and Safety of 300 mg versus 100 mg Fluorescein in Ultra-widefield Fluorescein Angiography: A Randomized Clinical Trial.

Abstract

Purpose: To compare the image quality and safety of ultra-widefield fluorescein angiography (UWFA) using 3 ml (300 mg) versus 1 ml (100 mg) of 10% fluorescein.

Methods: In this prospective, randomized clinical trial, a total of 144 patients who required UWFA examination for various retinal diseases were randomized 1:1 to 300 mg or 100 mg of fluorescein. Images were qualitatively graded by three retinal specialists and quantitatively analyzed. The primary outcome measure was the assessment of image quality (scored in a five-point scale). Quantitative sub-analysis among normal UWFA images through pixel intensity in posterior and mid-peripheral zone was also performed.

Results: A total of 67 participants in each group were included in the analysis. The mean difference of image quality between two dose groups was within the predefined non-inferiority margin of 0.5 (0.005; 95% confidence interval, -0.145 to 0.154). The mean pixel intensity showed no significant differences in both posterior and mid-peripheral zone (P = 0.988 and 0.726, respectively). In the safety analysis, significantly fewer adverse events were observed with the lower dose (300 mg, 10 of 67 [14.9%] vs. 100 mg, 3 of 67 [4.5%], P = 0.041).

Conclusion: We demonstrated the non-inferiority of image quality of low-dose fluorescein (100 mg) compared to a 300 mg dose with a reduction in the rate of adverse events associated with fluorescein angiography.